MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EV300; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ES2100X15B
Medical Device Problem Codes	Mechanical Problem (1384); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo device was returned to a service center for maintenance.There is no allegation of serious or permanent harm or injury.During the evaluation, a system setup test was performed on a trilogy evo device using the trilogy software, and it reportedly failed at step 3, which is the step that verifies proper valve operation, indicating a leak; therefore, both parts (the proportional (aecm) valve and three-way solenoid valves) will need to be replaced.The manufacturer's investigation is ongoing.If any additional information is received, a follow-up report will be filed.

• Brand Name: TRILOGY EV300
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 25475303
• Report Number: 2518422-2026-020995
• Device Sequence Number: 13244970
• Product Code: CBK
• UDI-Device Identifier: 00606959054097
• UDI-Public: (01)00606959054097
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ES2100X15B
• Device Catalogue Number: ES2100X15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown